4-Aminopyridine for Skin Wounds
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores whether a drug called 4-aminopyridine (4-AP) can accelerate wound healing. Researchers aim to determine if this treatment benefits individuals with both chronic (long-lasting) and acute (sudden) wounds. Participants will receive either the 4-AP treatment or a placebo (a pill with no active ingredient) for comparison. The trial suits healthy adults with a wound but no other skin conditions affecting their arms. Participants should follow a normal wound care plan and attend scheduled follow-up visits. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.
Will I have to stop taking my current medications?
The trial requires that you stop taking any aminopyridine medications, including other compounded 4-AP, and organic cat-ion transporter 2 (OCT2) inhibitors like Cimetidine.
Is there any evidence suggesting that 4-aminopyridine is likely to be safe for humans?
Research has shown that 4-aminopyridine (4-AP) is generally safe, based on past studies. It is already used for conditions like multiple sclerosis. In those cases, some people experienced side effects such as dizziness, trouble sleeping, and nausea, but these were uncommon, and only a few discontinued use due to these effects.
In animal studies, 4-AP accelerated wound healing without causing serious problems. Another study described 4-AP as a promising treatment with a strong safety record, particularly for healing wounds and burns.
Overall, while some mild side effects have been noted in other uses of 4-AP, it has been generally well-tolerated. This suggests it could be a safe option for aiding faster wound healing.12345Why do researchers think this study treatment might be promising?
4-Aminopyridine is unique because it offers a new way to aid skin wound healing by targeting nerve cell activity. Unlike current treatments that typically focus on cleaning wounds, preventing infection, or promoting tissue regeneration, 4-aminopyridine works by enhancing nerve transmission, potentially speeding up the healing process. Researchers are excited about this treatment as it taps into the body's nervous system to promote healing, which is a novel approach compared to standard wound care therapies.
What evidence suggests that 4-aminopyridine might be an effective treatment for wound healing?
Research has shown that 4-aminopyridine (4-AP) can accelerate wound healing. In animal studies, 4-AP helped skin wounds in mice heal faster by speeding up wound closure and aiding the skin's return to normal. It also reduced swelling and cell damage, both crucial for healing. Another study found that 4-AP promoted the growth of skin cells and hair follicles, which are key for wound recovery. In this trial, participants will receive either 4-AP or a placebo to evaluate its effectiveness in accelerating wound healing. These findings suggest that 4-AP could be a promising treatment for enhancing wound recovery.12567
Who Is on the Research Team?
John Elfar, MD
Principal Investigator
University of Arizona
Are You a Good Fit for This Trial?
This trial is for adults with chronic non-healing wounds or acute wounds. Participants should be in good health overall, aside from their wound condition.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive 4-aminopyridine or placebo for wound healing
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- 4-Aminopyridine
Trial Overview
The study tests if 4-aminopyridine (4-AP), a new agent thought to be safe, can speed up the healing of wounds. Some participants will receive 4-AP while others will get a placebo for comparison.
How Is the Trial Designed?
2
Treatment groups
Active Control
Placebo Group
dalfampridine (generic) 10 mg capsule po every 12 hours
Placebo-1 capsule po every 12 hours
Find a Clinic Near You
Who Is Running the Clinical Trial?
John Elfar
Lead Sponsor
Citations
4-Aminopyridine Induces Nerve Growth Factor to Improve ...
We now report that, in mice with full-thickness dorsal skin wounds, the systemic 4-AP treatment caused more rapid wound closure, restoration of normal epidermal ...
NCT06333171 | 4-aminopyridine for Skin Wound Healing
4-AP administration over just 21 days led to a large augmentation of wound healing at time points as early as three days post injury. 4-AP treatment was ...
4-aminopyridine promotes accelerated skin wound healing
We now provide evidence that 4-AP treatment of mice with acute skin wounds promotes faster wound healing, extensive changes in wound ...
4-aminopyridine attenuates inflammation and apoptosis ...
We recently found that 4-AP treatment enhanced wound healing and hair follicle regeneration by augmenting keratinocyte, fibroblast, and Schwann- ...
4-aminopyridine attenuates inflammation and apoptosis and ...
Our data supports a novel therapeutic application of 4-AP in promoting cutaneous burn healing, which is clinically translatable. Results. 4-AP expedited burn ...
Functional improvement in individuals with chronic spinal cord ...
The TEAEs most frequently associated with discontinuation were dizziness (8%), insomnia (4%) and nausea (3%). Only one serious adverse event ( ...
NCT06596434 | 4-Aminopyridine to Treat Skin Burns
More research is needed to evaluate the role of 4-AP, a promising new agent with an excellent safety profile, on wound and burn healing. The investigational ...
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